Paraffin Oil or Coconut Oil in Acute Aluminum Phosphide Poisoning

Aluminum Phosphide Poisoning Clinical Trial

Official title:

Gastric Lavage With Paraffin Oil or Coconut Oil in Management of Acute Aluminum Phosphide Poisoning: A Randomized Controlled Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04724655
• Other study ID #: oils and aluminum phosphide
• Status: Completed
• Phase: Early Phase 1
• Start date: January 1, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: June 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to evaluate safety and efficacy of gastric lavage with paraffin oil or gastric lavage with coconut oil in management of acute Aluminum phosphide poisoning.

Description:

60 patients will be randomly assigned as control groups, paraffin group, and coconut group in a 1:1:1 ratio (30 patients in each group).

Inclusion criteria:

• Patients with symptomatic acute aluminum phosphide poisoning

• Age is more than 12 years of both gender

• Patients presenting within 6 hours post-ingestion of aluminum phosphide (Papade and Vanjari, 2019).

The diagnosis is made on the basis of:

1. The suggestive clinical manifestations due to and following shortly after a single exposure to aluminum phosphide.

2. Reliable identification of the compound based on the container brought by patient attendants.

3. Biochemical detection of phosphine gas in gastric aspirate (silver nitrate test).

• Group (I): Gastric lavage with saline and sodium bicarbonate 8.4% then aspiration will be done after 3-5 min through nasogastric tube (Control group)

• Group (II): Gastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution 8.4%, then aspiration will be done after 3-5 min through nasogastric tube (Paraffin group).

• Group (III): Gastric lavage will be initiated with 50 ml coconut oil and 50 ml sodium bicarbonate 8.4 % then aspiration will be done after 3-5 min through nasogastric tube (Coconut group).

• All patients will continue to receive the standard supportive treatment according to Tanta University Poison Control Center protocol, which is determined by the attending physician who maintains clinical responsibility for all patients. Conventional standard treatment included using inotropes, fluids and electrolytes resuscitation, intubation, mechanical ventilation and antiarrhythmic agents if indicated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: September 15, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• • Patients with symptomatic acute aluminum phosphide poisoning

• Age is more than 12 years of both gender

• Patients presenting within 6 hours post-ingestion of aluminum phosphide

Exclusion Criteria:

• • Patients less than 12 years of age

• Pregnant and lactating women.

• Patients with ingestion or exposure to other substances in addition to aluminum phosphide.

• Patients with other major medical conditions (e.g. cardiovascular disease, diabetes mellitus, renal or hepatic failure).

Related Conditions & MeSH terms

• Aluminum Phosphide Poisoning
• Poisoning

Intervention

Other:
• gastric lavage with paraffin oil and bicarbonate
Gastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution 8.4%, then aspiration will be done after 3-5 min through nasogastric tube
• gastric lavage with coconut oil and bicarbonate
Gastric lavage will be initiated with 50 ml coconut oil and 50 ml sodium bicarbonate 8.4 % then aspiration will be done after 3-5 min through nasogastric tube

Drug:
• standard treatment
inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate

Other:
• gastric lavage with saline and bicarbonate
Gastric lavage with saline and sodium bicarbonate 8.4% then aspiration will be done after 3-5 min through nasogastric tube

Locations

Country	Name	City	State
Egypt	Tantau	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death		72 hours